Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial

RCT (n=9,302) was terminated early due to futility as the vaccine did not reduce C difficile infections vs placebo when used in patients considered to be at increased risk (0.29 vs 0.28 infections per 100 person years). Clinical development of this vaccine has stopped.

SPS commentary:

A related commentary confirms the disappointment with these results and states that future studies of primary C difficile infection prevention should include patients at the highest risk of C difficile infection, including those who are aged 50 years and older, have received antibiotics within 3 months of enrolment, and have at least one comorbidity (such as chronic kidney disease or diabetes), to enable a bigger effect size of the primary outcome.


The Lancet Infectious Diseases

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